Senior Specialist, Regulatory Affairs, Dispensing

Job Description Summary

The Senior Staff Specialist of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs. This position is responsible for supporting MMS Dispensing products consisting of non-Medical and Medical Devices and associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of developing and executing global regulatory strategy to support new product development, sustaining, and end of life activities.

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW
• Lead regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
• Problem solve and elevate regulatory and compliance issues to senior management as necessary
• Provide effective communication, and quick responses to internal customers
• Drive continuous improvement in internal processes and customer satisfaction
• Identify, develop, and mentor high performing regulatory talent
• Develop and implement global regulatory strategy for MMS Dispensing products and software
• Assure that QSMR requirements are followed and executed consistently from RA perspective
• Execute Technical File creation and remediation, collaborating with cross-functional teams for required content
• Draft and execute comprehensive regulatory impact assessments for design control changes to existing products
• Performs other duties and assignments as required

• Bachelor's degree in biology, engineering, or other science-related discipline
• Minimum of 5 years of directly related Regulatory Affairs experience in medical devices
• Experience with Regulatory and Quality Information Management systems (SAP, RIM, or related systems.
• Digital literacy in MS Word, Excel, PowerPoint, Teams
• Project Management experience

• Advanced degree (e.g., MS, PhD)
• RAPS RAC certification

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction…